TerminatedNot Applicable

Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding

Stopped: Slow accrual

United States15 participantsStarted 2024-05-10

Plain-language summary

In this study, researchers want to learn about the connection between heavy bleeding issues and joint hypermobility (loose joints). They want to know if these issues may indicate other connective tissue problems in girls and women with heavy menstrual bleeding who do not have a known cause. Primary Objective * Compare the severity of heavy menstrual bleeding (HMB) in women with and without Generalized joint Hypermobility Syndrome Disorder/hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using bleeding scores. Secondary Objectives * Compare the frequency of co-morbidities in women with and without G-HSD/hEDS.

Who can participate

Age range

12 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female * Age 12-40 years * Presence of HMB * Evidence of severe iron-deficiency anemia (hemoglobin level of \< 8 g/dL) Exclusion Criteria: * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Current use of anticoagulant and antiplatelet medications * Currently pregnant * Medical conditions that could cause HMB but are not necessarily a bleeding disorder, including, but not limited to: * Uncontrolled hypertension * Documented uterine structural abnormality * Insulin-dependent diabetes mellitus * Chronic kidney disease * Chronic liver disease * Thyroid disease * Documented peripheral arterial disease, venous or arterial vascular events in the past * A structural pathology that would explain the HMB * Presence of a bleeding disorder indicated by prothrombin time, activated partial thromboplastin time, fibrinogen, and von Willebrand factor activity, antigen and factor VIII * Persistent thrombocytopenia as defined by a platelet count of \<150,000/uL * If the participant answers "yes" to any of the following questions, they are ineligible: * Could the patient have a known connective tissue disorder? * Family history of sudden death * Family history/personal history of uterine rupture or bowel perforation * Family history/personal history of arterial rupture * Family history/personal history of aneurysm * Family history/personal history of an established EDS d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Severity of bleeding symptoms in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Self-Bleeding Assessment Tool (Self-Bat)

Timeframe: Yearly for 3 years

Number of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).

Timeframe: Approximately 3 years

Proportion of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).

Timeframe: Approximately 3 years

Trial details

NCT IDNCT05685199

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-06

View on ClinicalTrials.gov More Hypermobile Ehlers-Danlos Syndrome trials

Plain-language summary

Who can participate

Age range

12 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Severity of bleeding symptoms in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Self-Bleeding Assessment Tool (Self-Bat)

Timeframe: Yearly for 3 years

Number of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).

Timeframe: Approximately 3 years

Proportion of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).

Timeframe: Approximately 3 years